Clinical trial · Interventional
Rectal Spacers Use in Prostate Cancer Radiation Therapy
Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer: Prospective Clinical Study
NCT06594887CI-TRIAL-00080710active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study. Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BioProtect Balloon Implant System | Device | — | UNRESOLVED |
| SpaceOAR Vue | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SpaceOAR Vue
- interventionNames
- Device: SpaceOAR Vue
- type
- EXPERIMENTAL
- label
- BioProtect Balloon Implant System
- interventionNames
- Device: BioProtect Balloon Implant System
Primary outcomes (1)
- measure
- Perirectal distance
- timeFrame
- 2-4 months
- description
- Perirectal distance evaluated by measurement of the prostate-rectum separation as measured on treatment planning CT simulation.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Subjects greater than 18 years old with prostate cancer 2. Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer 3. Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer 4. PSA less than or equal to 20 ng/mL 5. Gleason Score less than or equal to 7 6. Capacity to comprehend and readiness to sign a written informed consent form Exclusion Criteria 1. Planned Pelvic lymph node radiotherapy. 2. Metastatic disease. 3. Prior local prostate cancer therapy 4. Active Inflammatory bowel disease requiring treatment with steroids. 5. Prior radical prostatectomy. 6. Active urinary tract infection. 7. Acute or chronic inflammation or infection of the prostate.
References
Publications (0)
Data not yet available
No reference posted for this study.